Sleeve Gastrectomy Calibration Tube And Method Of Using Same

ABSTRACT

One or more medical devices may be provided that may be used, for example, in bariatric surgery including a vertical sleeve gastrectomy. The one or more medical devices may include a laparoscopic sleeve gastrectomy stapling guide in conjunction with a calibration tube in accordance with one or more examples. According to an example, the calibration tube may be a flared, multi-diameter calibration tube. The flared, multi-diameter calibration tube may have a first diameter along a portion of the tube and a second diameter that may larger than the first diameter along at least another portion of the tube. The calibration tube may be used in conjunction with the stapling guide to align stomach such that it may be stapled along the stapling guide (e.g., to perform the vertical sleeve gastrectomy).

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/846,764, filed Sep. 5, 2015, which claims the benefit of U.S.Provisional Application No. 62/046,598, filed Sep. 5, 2014, thedisclosures of which are incorporated herein by reference in theirentireties.

TECHNICAL FIELD

The examples herein may be directed to a sleeve gastrectomy, and moreparticularly to a calibration tube inserted into the stomach and used inconjunction with a sleeve gastrectomy stapling guide or a sleevegastrectomy stapler such as a full length sleeve gastrectomy stapler.The example devices herein may provide a minimum safe distance from theincisura angularis and other stomach landmarks during the creation of avertical sleeve gastrectomy.

BACKGROUND

Obesity is a disease that affects a significant portion of the world'spopulation and leads to multiple chronic medical conditions andpremature death from cardiovascular events and cancer. In particular,the United States has a current, and worsening obesity epidemic. TheU.S. Centers for Disease Control and Prevention (CDC) reports that over33% of the US. population is obese, with a Body Mass Index (BMI) of over30, and another 35-40% of the US population is overweight, with a BMI of25-30. The CDC reports that the percent of the US population beingeither overweight or obese by 2018 will be 75%. The CDC also reportsthat obesity directly costs the U.S. economy $147 billion currently, andprojects that the costs will approach $315 billion by 2020.

Further, obesity has environmental, genetic and behavioral origins butis intractable to most medical and behavioral interventions. To helpreduce obesity and/or facilitate weight loss, bariatric surgery may bean option for some patients that may be overweight. Typically, bariatricsurgery may be an effective long-term treatment option for patients witha BMI greater than 35. Despite the 20 million patients who are eligiblefor weight loss surgery in the U.S., the number of procedures per yearhas plateaued at about 200 thousand, eliminating any public healtheffect of surgery.

In recent years, a popular form of bariatric surgery may include alaparoscopic vertical sleeve gastrectomy (e.g., which may removeapproximately 80% of the stomach). Laparoscopic vertical sleevegastrectomy may be a procedure that may be safer and more effective forpatients eligible for weight loss surgery. In fact, it has been acceptedas the surgery that should be offered to most morbidly obese patientsover, for example, laparoscopic adjustable gastric banding andlaparoscopic Roux-en-Y gastric bypass. As such, the surgery has beenadopted by bariatric surgeons and is now the most commonly performedweight loss surgery.

Vertical sleeve gastrectomy is typically performed using standardlaparoscopic equipment. The greater curvature of the stomach ismobilized using vessel-sealing devices, sealing the gastric branches ofthe gastroepiploic vessels and the short gastric vessels. The posterioradhesions of the stomach are also divided so the stomach is fullymobilized while the blood supply to the lesser curvature remains intact.

Following mobilization of the stomach a calibration tube is typicallyintroduced into the stomach through the mouth. Resection is accomplishedby applying a series of staples from a laparoscopic linear surgicalstapler, for example, along the calibration tube in a staple line. Thestaple line may be important in sleeve gastrectomy as the amount ofweight lost and complications or consequences may be a direct result ofthe quality of the resultant sleeve gastrectomy pouch formed from thestaple line (e.g., the portion of the stomach not rescinded by thestaple line). The complications or consequences may includegastroesophageal reflux disorder (GERD), weight loss failure or weightregain, food intolerance, staple line bleed, leak, and/or the like.

To help produce a repeatable sleeve gastrectomy pouch (e.g., from thestaple line), a sleeve gastrectomy stapling guide and calibration tubewith a constant diameter may be used. Although the combination of thestapling guide and calibration tube may help produce a better stapleline and, thus, sleeve gastrectomy pouch, a surgeon may still need toestimate or envision an adequate distance from one or more parts of thestomach such as the IA to not create a stricture at that point with thestaple line. Other efforts, devices, and techniques such as ballooncatheters, bougies, and/or the like have been made to improve thecalibration and, thus, location of the staple line such thereby needingless estimation by the surgeon. Unfortunately, such efforts still makeit difficult for a surgeon to envision the staple line and may not helpensure that proper distances are maintained from each landmark along thestomach as the surgeon may still need to estimate distances to createthe staple line.

SUMMARY

In an example herein, one or more medical devices may be provided thatmay be used, for example, in bariatric surgery including a verticalsleeve gastrectomy. The one or more medical devices may include alaparoscopic sleeve gastrectomy stapling guide in conjunction with acalibration tube in accordance with one or more examples. According toan example, the calibration tube may be a flared, multi-diametercalibration tube. The flared, multi-diameter calibration tube may have afirst diameter along a portion of the tube and a second diameter thatmay larger than the first diameter along at least another portion of thetube. The calibration tube may be used in conjunction with the staplingguide to align stomach such that it may be stapled along the staplingguide (e.g., to perform the vertical sleeve gastrectomy). In examplesherein, the one or more devices (e.g., the calibration tube and/or thestapling guide) may provide a proper distance (e.g., a minimum safedistance) from the incisura angularis and other stomach landmarks duringthe creation of a staple line for the vertical sleeve gastrectomy andmay be used to create a repeatable resultant sleeve size of the stomach.For example, a surgeon may have a good idea of what size the resultantsleeve size should be, but the shortcoming of current methods, medicaldevices, and/or the like may lie in how they may be used to create andrepeat such a sleeve—both between different surgeons, and for eachsurgeon from patient to patient. The use of the flared, calibration tube(e.g., with the different diameters) along with the staple guide mayenable a surgeon to create the resultant sleeve size they desire, and asize they know works for effective weight loss while at the same timemay improve a surgeon's ability to line up each staple fire and createthe resultant sleeve that may be more consistent and repeatable.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts the flared calibration tube complete with a valve forregulated suction and perforations to allow for suction and injection ofmaterial into the stomach.

FIG. 2 depicts a zoomed-in look at the tip of the flared calibrationtube, indicating the cylindrical flared portion along with theperforations.

FIG. 3A depicts the suction regulation valve of the flared calibrationtube in the “open” position.

FIG. 3B depicts the suction regulation valve of the flared calibrationtube in the “closed” position.

FIGS. 4-9 depicts an enlarged view of one or more additional oralternative examples of a flared portion that may be included in theflared, calibration tube.

FIGS. 10-12B depicts an enlarged view of one or more additional oralternative examples of a flared portion that may be included in theflared, calibration tube.

FIG. 13A is the formula used to calculate resultant sleeve circumferencebased on stapling guide width and calibration tube circumference.

FIG. 13B is the formula used to calculate resultant sleeve diameterbased on stapling guide width and calibration tube diameter.

FIG. 14A depicts a cross-section view of what the calibration tube andstapling guide combination will look like, with the adjacent resectionline along the guide.

FIG. 14B then depicts the resultant size of the sleeve once thecalibration tube and stapling guide have been removed.

FIG. 15 depicts the flared calibration tube once it has been inserted tothe pylorus of the stomach.

FIG. 16 depicts the stapling guide being positioned around the stomach.

FIG. 17 depicts the stapling guide being positioned at thegastroesophageal junction, in the approximate location of where theresection line will occur.

FIG. 18 depicts the calibration tube being pulled up from the pylorusand positioned along the incisura angularis, forcing the stapling guideto move laterally into the appropriate position to prepare for staplingand cutting.

FIGS. 19-23 illustrate an additional or alternative example method orprocedure that may be performed using the flared, calibration tube inone or more examples.

FIGS. 24-28 illustrate an additional or alternative example method orprocedure that may be performed using the flared, calibration tube inone or more examples.

FIG. 29 depicts a calibration tube that is meant to generally representthe alternative embodiments listed above, used in conjunction with thestapling guide to assist in guide and resection line alignment.

FIG. 30 depicts the resultant sleeve after the stapling and cutting hasbeen executed. The resection line is about 2 cm off the incisuraangularis, about 1 cm off of the GE junction, is vertical, and hascomplete fundus removal.

FIG. 31 depicts a calibration tube in accordance with another embodimentof the invention and used in conjunction with a stapling guide to assistin guide and resection line alignment.

FIG. 32 depicts a calibration tube in accordance with another embodimentof the invention and used in conjunction with a stapling guide to assistin guide and resection line alignment.

FIG. 33 depicts a table illustrating different sizes of the flared,calibration tube and/or the stapling guide that may provide differentsizes to a resultant sleeve of a stomach in one or more examples herein.

DETAILED DESCRIPTION

As described herein, systems and/or methods may be provided forperforming a sleeve gastrectomy. For example, a first medical device maybe positioned in an interior of the stomach. The first medical devicemay include or have a first diameter along a first portion thereof(e.g., a calibration or medical tube) and a second diameter that may belarger than the first diameter along a second portion thereof (e.g., aflared portion or a radially-outward projecting portion of a medicaltube). The first medical device may be positioned, for example, byinserting the first medical device into a mouth of a patient to accessthe interior of the stomach and positioning the second portion at alandmark (e.g., a first landmark such as an incisura angularis (IA)) ofthe stomach. According to an example, the first medical device may bemoved proximally and/or distally (e.g., from a first position to asecond position) to position the first medical device at the landmark.

Further, in one example, a second medical device such as a clamp orstapler may be positioned on an exterior of the stomach relative to orbased on an interaction with the first medical device (e.g., adjacentto, near, in proximity to, and/or interaction with the second portion ofthe first medical device) such that the second medical device may beconfigured to demonstrate or create a path such as a resection line orstaple line) along the stomach at which the sleeve gastrectomy may beperformed. As such, the first medical device may be used as a referenceto position the second medical device. For example, an interaction(e.g., positioning the second medical device relative to the firstmedical device may position the second medical device in a desiredposition to demonstrate or provide the path. In one example, movement ofthe first medical device causes a corresponding movement or sliding ofthe second medical device (e.g., from a first position to a secondposition) along the exterior of the stomach to position the secondmedical device in the desired position to demonstrate the path. Thesecond medical device may be fixed relative to another landmark and/oradditional landmarks of the stomach (e.g., a second and/or a thirdlandmark) as part of its positioning to create and/or demonstrate thepath.

In additional examples, the first medical device itself may createand/or demonstrate the path to perform the sleeve gastrectomy asdescribed herein (e.g., without use of the second medical device). Insuch an example the path may be demonstrated and/or created along thesecond portion (e.g., the flared portion) of the first medical device(e.g., the tube).

The sleeve gastrectomy (e.g., resection of part of the stomach) may beperformed along the path thereby producing a resultant sleeve of thestomach. For example, a resection or staple line may be created (e.g.,using a surgical stapler) along the path thereby producing the resultantsleeve. In one or more examples herein, the resultant sleeve of thestomach that may be created by the path (e.g., the resection or stapleline) may include a diameter of approximately 1 to 3 cm near the firstlandmark (e.g., the IA), approximately 2 to 6 cm near a second landmark(e.g., a pylorus) of the stomach, and approximately 0 to 2 cm near athird landmark (e.g., a gastroesophageal junction (GEJ or GE junction))of the stomach.

In one example, the first medical device may be a flared, multi-diametercalibration tube and may include a tube that may include a flaredportion at a distal end thereof. In an example, the tube may be thefirst portion and the flared portion may be the second portion. The tubemay have or include a first diameter (e.g., a constant diameter asdescribed herein) that may be proximal and distal to the flared portion.The flared portion may have or include a second diameter (e.g., amaximum diameter as described herein) that may be larger than the firstdiameter. As described herein, the tube (e.g., that may be the firstmedical device or part of the first medical device) may be configured tobe inserted or may be inserted into an interior of the stomach and theflared portion may be positioned at a first landmark thereof (e.g., theIA) such that the flared portion that may be positioned at the firstlandmark may be configured to facilitate alignment of a resection lineor staple line (e.g., the path) during the sleeve gastrectomy thatproduces the resultant sleeve described herein. For example, the flaredportion may include a first point and a second potion at an opposite endthereof forming the second diameter thereacross. The first point of theflared portion may be configured to be positioned near the firstlandmark as described herein and the second point of the flared portionmay be configured to form the resection line (e.g., a line that includesthe second point) that produces the resultant sleeve.

In an example, alignment of resection or staple line may further befacilitated by the second medical device (e.g., a clamp or stapler)positioned relative to the first medical device. For example, the flaredportion may include a first point and a second point at an opposite endthereof forming the second diameter thereacross. The first point of theflared portion may be configured to be positioned near the firstlandmark as described herein and the second medial device may beconfigured to be positioned near the second point of the flared portionto form the resection line (e.g., a line along a side of the clampopposite of the side positioned near the second point) that produces theresultant sleeve.

FIG. 1 depicts the flared calibration tube complete with a valve forregulated suction and perforations to allow for suction and injection ofmaterial into the stomach. As shown in FIG. 1, a flared, calibrationtube 12 (e.g., a first medical device) in accordance with one or moreexamples herein may be provided. According to an example herein, theflared, calibration tube 12 may be used in conjunction with a secondmedical device (e.g., a clamp or a surgical stapler) as described herein(not shown in FIG. 1 but an example of which may be shown as staplingguide 88 in FIGS. 15-32) to perform a vertical sleeve gastrectomy. In anexample, the flared, calibration tube 12 may have a first diameter alonga portion thereof that may be constant (e.g., 6) and a second diameteralong another portion thereof (e.g., 2) that may be larger than thefirst diameter as described herein.

For example, as shown, the flared, calibration tube 12 may include atube 14 (e.g., a first portion of the first medical device orcalibration tube) and a suction regulation valve 16 that may cap thetube 14 (e.g., a body of the tube 14). As shown, the tube 14 may begenerally cylindrical in shape and may be made of, for example, rubber,silicone, polyurethane, a plastic polymer, and/or any other suitablematerial. The tube may be hollow, solid, and/or the like in one or moreexamples. The tube 14 may include a proximal end PE that may be closerto a surgeon that may interact with the flared, calibration tube 12 to adistal end DE that may be farther away from the surgeon. As shown, thetube 14 may include a lower tip 10 at the distal end DE and a flared outportion 3 (e.g., a second portion of the first medical device orcalibration tube) and may be capped off by the suction regulation valve16 at the proximal end PE.

The lower tip 10 of the tube 14 may be long enough to allow for easyinsertion into the mouth, esophagus, and stomach, and/or may enable orallow the tube 14 of the flared, calibration tube 12 to be navigateddown to the pylorus of the stomach. Moving proximally up from the lowertip 10 at the distal end DE, the tube 14 (e.g., the generallycylindrical shape of the tube 14) may include a flared portion 3 (e.g.,a cylindrical flared portion).

FIG. 2 depicts an enlarged view of the lower tip 10 of the tube 14 thatmay be included in the flared, calibration tube 12 including the flaredportion 3. As shown in FIG. 2, the tube 14 may begin to flare out 4 fromthe constant diameter 6 until it reaches the maximum diameter 2 at whichpoint it may begin to flare in 5 until it may return back to theconstant diameter 6 thereby forming the flared out portion 3. Asdescribed herein, the flared out portion 3 may be used to align andcalibrate a stapling guide such that a more accurate staple line (e.g.,path or resection line) may be formed for resection during the verticalsleeve gastrectomy according to examples herein. As shown, the maximumdiameter 2 may be formed by points (e.g., a first and second point suchas P and P′) at opposite ends or sides of the flared portion 3.

In an example, the flared portion 3 may be approximately 2 cm long fromthe beginning of the flare 4 to the end of the flare 5. Further, asshown, the maximum diameter 2 of the flared portion 3 may beapproximately. Additionally, as described herein (e.g., above), theflared portion 3 may narrow at 4 and 5 until it may return to theconstant diameter 6 (e.g., that may be substantially maintainedthroughout the rest of the tube 14). Example dimensional ranges of theconstant diameter portion 6 of the tube may be from 0.3 cm to 1.5 cm andexample dimensional ranges of the flared portion 3 are contemplated torange from 0.5 cm to 2.0 cm (e.g., including the maximum diameter 2).Such ranges may be provided based on a spacer (e.g., the spacer 60) thatmay be 1 cm in width according the formulas F1 and F2 described withrespect to FIGS. 13A-13B and 14A-14B. In one or more examples, theresultant sleeve diameter range may be 1 cm (or 30 French) to 2 cm (or60 French) for the cylindrical portion near or above the incisuraangularis (e.g., a first landmark), may be 2 cm to 6 cm for the portionnear the pylorus (e.g., a second landmark), and/or 0 cm to 2 cm for theportion near the GEJ (e.g., a third landmark). The flared portion 3 mayhave a wider resultant sleeve diameter of 1.2 cm (or 36 French) to 2.6cm (or 78 French) according to examples herein.

As shown in FIG. 2, according to one example, the flared portion 3 maybe integrally formed as part of the tube 14, for example, duringmanufacturing. In additional or alternative examples, the flared portion3 may be separately coupled and/or fixedly attached to the tube 14and/or may include two separate pieces (e.g., as shown in FIGS. 4-8). Inadditional embodiments, the flared portion 3 may be a constant diameter(e.g., the constant diameter 6) and/or a smaller diameter than theconstant diameter 6 until use of the flared, calibration tube 12 duringthe vertical sleeve gastrectomy during which the flared portion 3 may beenlarged to the maximum diameter 2 by inflation and/or actuation such asmechanical actuation (e.g., as shown in FIGS. 10-12).

In examples herein, the diameter 2 of the flared out portion 3 may beused as a form of alignment and calibration, and/or may be the point atwhich a stapling guide (not shown in FIG. 1 and which may be shown as 88in FIGS. 15-32) may be positioned adjacent to an incisura angularis (IA)(e.g., not shown in FIG. 1 and which may be shown as 40 d in FIGS.15-32). As such, the flared, calibration tube 12 (e.g., via tube 14) mayinclude a constant diameter 6 and a maximum diameter 2 (e.g., Di in FIG.13A) of a flared portion 3 such that the flared, calibration tube 12 mayenable a surgeon to more reliably create a sleeve pouch with a different(wider) diameter at the IA (e.g., D2 in FIG. 13B) than the GE junction.In such an example, the stapling guide may be used as a spacer,otherwise, the flared portion 3 may not fit past the narrower uppersleeve of the stomach (e.g., 40 e as shown in FIGS. 15-18).

In an example, as shown in FIG. 2, the tube 14 may include one or moreperforations 26. For example, as shown, the lower tip 10, the flaredportion 3, and/or a portion of the tube 14 proximal to the flaredportion include the one or more perforations 26 therein. In an example,the one or more perforations 26 may be holes in the tube 14 that may beused to collect or suction tissue debris from the stomach that may besuctioned proximally up through the tube 14 during the vertical sleevegastrectomy and expunged therefrom as described herein.

Referring back to FIG. 1, the body of the tube 14 may be capped 24 by asuction control valve 16 that may be used to regulate when and howsuction may be applied to the distal end DE (e.g., shown in FIG. 2) ofthe tube 14. As shown, the suction control valve 16 may include a switch22 that may be used to open and/or close the suction control valvethereby allowing and/or not allow air flow through the tube.

FIG. 3A depicts the suction control valve 16 of the flared, calibrationtube 12 in an “open” position 20. In an example, when the switch 22 ofthe valve 16 may be in the “open” position 20, air may flow out of thetube 14 through an opening at a proximal tip 18 of the flared,calibration tube 12. As described herein, in the “open” position 20, thesuction control valve 16 may enable tissue debris to be removed duringthe vertical sleeve gastrectomy and expunged therefrom as describedherein. For example, the debris that may be collected by the one or moreperforations 26 may be suctioned through the tube 14 and out of theopening in the proximal tip 18 when the suction control valve 16 may bein the “open” position 20.

FIG. 3B depicts the suction control valve 16 of the flared, calibrationtube 12 in a “closed” position 28. According to an example, when theswitch 22 of the valve 16 may be in the “closed” position 28, air maynot flow out (e.g., air may be blocked) of the tube 14 through theopening at a proximal tip 18 of the flared, calibration tube 12. In the“closed” position 28, tissue debris may not be expunged and/or removedduring the vertical sleeve gastrectomy.

FIGS. 4-8 depicts an enlarged view of one or more additional oralternative examples of the flared portion 33 that may be included inthe flared, calibration tube 12. As shown in FIGS. 4-6, a separate,flared portion 33 (e.g., that may have the same or similar propertiesincluding the maximum diameter 2, and/or the like as described hereinwith respect to the flared portion 3) may be coupled or attached onto anexisting stock gastric tube 34 (e.g., that may have the same or similarproperties including the constant diameter 6, and/or the like asdescribed herein with respect to the tube 14). This may enable theflared portion 33 (e.g., the add on) to be sold separately and assembledat bedside or prior to the surgery. In examples herein, the flaredportion 33 may be slid onto the tube 34, may be snapped around the tube34, may be glued on the tube 34, and/or may be coupled and/or fixedlyattached to the tube 34 using any other suitable coupling or attachmentmechanism. The flared portion 33 may include and/or have a tapered face(e.g., similar to the flared portion 3 tapering to 4 and 5) to slidealong the oropharyngeal, esophageal and gastric mucosa without damagingthe mucosal surfaces and/or getting snagged. The flared portion 13 maybe made rubber, silicone, polyurethane, a plastic polymer, and/or anyother suitable material.

FIGS. 5A-5B illustrate examples of the flared portion 33 that may becoupled or attached onto the tube 34. As shown in FIG. 5A, the flaredportion 33 may include a first flared portion 40 and a second flaredportion 42. As shown, the first flared portion 40 and the second flaredportion 42 may have crevices 44 a, 44 b respectively. The crevices 44 a,44 b may be convex depression that may extend along the outer diameterof the tube 34 and may when combined take the shape of the outerdiameter of the tube 34. For example, when the first and second portions40, 42 may coupled or attached together (e.g., connected via one or moresnaps (not shown), glue, and/or the like), the crevices 44 a, 44 b mayreceive and surround the tube 34. As shown in FIG. 5B, the first andsecond portions 40, 42 may include a hinge 48 a, 48 b that may be usedto pivot the first and second portions, 40, 42 to surround the tube 34.

In an example, as shown in FIG. 6, the flared portion 33 may be usedwith different diameter tubes. For example, the flared portion 33 mayinclude and/or have a gripping surface 50 and a screw 52 and/or cap 54that may be inserted into one or more sides of the tube 34. The grippingsurface 50 may include teeth 51 that may be used to prevent the flaredportion 33 from sliding up and down the tube 34. For example, the flaredportion 33 may be slid over the tube 34 and the teeth 51 of the grippingsurface 50 may help secure the flared portion 33 at the appropriatelocation on the tube 34 thereby preventing the flared portion 33 fromsliding freely up and down the tube 34. In one example (e.g., once theflared portion 33 may be positioned at the appropriate location), thescrew may be inserted over the tube 34 and screwed, for example, in adistal end of the flared portion 33 and the cap 52 may be inserted overthe tube 34 and snapped into a proximal end of the flared portion 33thereby further securing the flared portion 33 on the tube 34 andpreventing movement thereof.

According to examples, as shown in FIGS. 7-8, a tube with two diameters(e.g., a first and second diameter) and/or a first and second tube 64,74 may be inserted within each other may be used to form a flaredportion 73 (e.g., that may have the same or similar properties includingthe maximum diameter 2, and/or the like as described herein with respectto the flared portion 3). For example, the first tube 64 may include a16 or 18 French polymer or latex orogastric tube that may be used as thesmaller diameter tube (e.g., that may have the same or similarproperties of the tube 14 including the constant diameter 6, and/or thelike). The second tube 74 may include a tapered wider section of a tube(e.g., a polymer or latex orogastric tube) with an inner diameter thatmay be equivalent to, larger, and/or substantially similar to the outerdiameter of the tube 14 (e.g., constant diameter 6) and an outerdiameter equivalent to the diameter of the flared portion 3 (e.g., themaximum diameter 2). Further, as shown in FIG. 8, the tube 74 may tapersimilar to the tapering 4,5 of the flared portion 3. According to anexample, the second tube 74 may be slid over and positioned at theappropriate location on the first tube 64 (e.g., a locationapproximately near the distal end 10 similar to the flared portion 3).The second tube 74 (e.g., once positioned) may be fixedly attachedand/or coupled to the first tube 64 via any suitable technique includingsolvent bonding via a solvent bond 75.

FIG. 9 illustrates an example of one or more lights that may be includedin the flared portion 3, 33, and/or 73 in one or more examples. Forexample, the flared portion 3, 33, and/or 73 (e.g., the wider section)of the tubes 14, 34, and/or 74 (e.g., that may be combined with the tube64) may be fitted with lights 78, 79 such as LED or fiber optic lightsto better visualize the position of the tube within the stomach.According to an example, having lights 78, 79 that may indicate theflared portion may enable or the surgeon to accurately place the widerportion of the calibration tube adjacent the incisura angularis (IA).

FIGS. 10-12B depicts an enlarged view of one or more additional oralternative examples of the flared portion 83 that may be included inthe flared, calibration tube 12. As shown in FIG. 10, in one example, atube 84 that may be included in the flared, calibration tube 12 mayinclude a first diameter D1′ that may be adjustable to a second diameterD2′ to form the flared portion 83. For example, the tube 84 may includea balloon 86 that may be used to form the flared portion 93. The balloon86 may be relaxed or deflated prior to use and insertion of the flared,calibration tube 12 in the stomach. In such an example (e.g., prior toinsertion and use), the tube 84 with the balloon 86 in the relaxed ordeflated state 51 may have a substantially constant diameter (e.g.,similar to the constant diameter 6). The first diameter D1′ may be thesubstantially constant diameter. The balloon 86 may be inflated to aninflated state S2 upon insertion of the tube 84 that may be part of theflared, calibration tube 12 into the stomach to the appropriate positionsuch as adjacent to the incisura angularis and interaction therewith.According to an example, the inflated state S2 may form the flaredportion 83 that may have the second diameter D2′ (e.g., similar to themaximum diameter 2). The tube 84 with the flared portion 83 formed bythe balloon 86 may enable the staple line to be performed with a singlecartridge sleeve gastrectomy stapler. For example, the tube 84 may beplaced with the balloon 86 adjacent the incisura angularis (e.g., asdescribed in FIGS. 24-28 below) in the state 51. The stapler may thenplaced in apposition but not fully clamped, the balloon may be inflatedto the state S2 to form the flared portion 83, and the flared portion 83formed by the the balloon 86 in the state S2 may widen the area adjacentthe incisura angularis prior to stapling. After stapling, the balloon 86may be deflated to state 51 such that the tube 84 may return to thefirst diameter D1′ and may be removed.

Further, as shown in FIG. 11, a tube 94 that may be included in theflared, calibration tube 12 may include a first diameter DI″ that may beadjustable to a second diameter D2″ to form the flared portion 93. Forexample, the tube 94 may include a split tube 95 at a distal end (e.g.,the distal tip 10) and a solid portion 96 (e.g., that may haveproperties similar to the tube 14 including the constant diameter 6)extending proximally from the split tube 95 and the distal end. Thesplit tube 95 may be used to form a flared portion 93 (e.g., that mayhave similar properties to the flared portion 3) similar to the balloon86 used in the tube 84 described with respect to FIG. 10. In an example,the split tube 95 may include a first portion 98 and a second portion 99that may be widened to form the flared portion 93. For example, thesplit tube 95 may be relaxed or compressed prior to use and insertion ofthe flared, calibration tube 12 in the stomach. In such an example(e.g., prior to insertion and use), the first and second portions 98, 99of the split tube 95 may be in contact with each other in a relaxed orcompressed state 51′ such that the split tube 95 may have asubstantially constant diameter (e.g., that may be similar and/orsmaller than the constant diameter 6) that may be diameter D1″. Thesplit tube 95 may be widened (e.g., the first and second portions 98, 99may be separated) from the relaxed or compressed state 51′ to anexpanded state S2′ that may form the flared portion 93 upon insertion ofthe tube 94 into the stomach to the appropriate position such asadjacent to the incisura angularis and interaction therewith (e.g.,similar to that described in FIGS. 24-28). Such an interaction mayinclude, for example, shortening a distance from the distal tip to thesolid portion of the tube 94 by pulling on a control element (e.g., atthe proximal end of the tube 94 not shown). As shown, in the secondstate S2′, the first and second portions 98, 99 of the split tube 95 maybe adjusted from the first diameter DI″ to a second diameter D2″ (e.g.may become wider along an x-axis) the first and second portions 98, 99may be wider along the x axis. In additional or alternative examples,the split tube 95 may include three portions, four portions, and/or thelike that may be expanded and/or become wider along the x and z axes toform the flared portion 93.

In an example as shown in FIG. 12A-12B, a tube 104 may include a bowingout portion that may be used to form the flared portion 103 that may beincluded in the flared, calibration tube 12. As described herein thetube 104 may include one or more properties similar to the tube 4 suchas the constant diameter 6, and/or the like. Similarly, the flaredportion 103 that may be formed may include one or more propertiessimilar to the flared portion 3 such as the maximum diameter 2 (e.g.,upon actuation and/or insertion). The flared portion 103 may be formedfrom bowing out a sail 105 attached to the tube 104 using a sheath 106.For example, the tube 104 may have a sail portion 105 (e.g., a portionthat bows out) that may be connected to the tube 104 at the distal endand a second point 20 to 30 cm proximally. Alternatively, the sailportion 105 is connected distally and extends beyond the proximal end oftube 104. In this configuration, the sail portion 105 is extendable whenportion extending beyond tube 104 is pushed into tube 104 andretractable when portion extending beyond tube 104 is lengthened. Thesail portion 105 may be adjusted to form the fared portion 103, forexample, by applying force thereto using a sheath 106, and/or the like.For example, the flared, calibration tube 12 may include a sheath 106.The sheath 106 may be inserted over the tube 104 at the proximal end(e.g., PE) to apply the force to the sail portion 105 thereby adjustingthe sail portion 105 to form the flared portion 103 relative to tube104. In an example, the tube 104 with the sail portion 105 may beinserted into the stomach and positioned such that the flared portion103 when formed may be adjacent to the incisura angularis. The sheath106 may then be pushed distally down the tube 104, and may be moveddistally and/or proximally to form and adjust the area that bows out toform the flared portion 103. In an example, the sail portion 105 may becombined with either a stapler or a stapling guide to make the flaredportion 103 and/or the resultant sleeve formed thereby wider at theincisura angularis.

FIGS. 13A-13B depict example formulas, F1 and F2, that may be used tocalculate a resultant sleeve circumference and diameter, respectively,based on stapling guide width and calibration tube circumference,respectively.

As described herein, using the flared, calibration tube with a sleevegastrectomy stapling guide may help to create a repeatable sleevegastrectomy anatomy based on a size a surgeon may want to achieve fortheir patient. The formulas

${F\; 1},{{C_{1} + {2L_{1}}} = C_{2}},{{and}\mspace{14mu} F\; 2},{{D_{1} + \frac{2L_{1}}{\pi}} = D_{2}},$

may be used such that the flared, calibration tube and the staplingguide or clamp may create a reproducible sleeve diameter. In examples,D₁ represents the diameter of the calibration tube used and C₁represents its circumference (e.g., at the IA, or the narrowest point),L₁ represents the distance/width of the (e.g., top and bottom) staplingguide, D₂ represents the diameter of a resultant sleeve size, and/or C₂represents its resultant circumference.

For example, a surgeon may aim or want to create a resultant sleeve sizeequivalent to using that of a 36 French (Fr) bougie (or 1.2 cm), whichmay be D₂. If the stapling guide may be 1 cm in width (L₁), using theformula F2, the diameter of the calibration tube may be approximately0.5634 cm (D₁), or 16.9014 Fr. As such, to create a sleeve sizeresultant of using a 36 Fr bougie, a 16.9 Fr flared, calibration tubeshould be used in conjunction with a stapling guide.

As described herein, one of the main focuses of this process, and thecalibration tube, is the fact that it keeps the resection line at least2 cm off of the IA. The desired resultant diameter above was 36 Fr, butthis is only equivalent to 1.2 cm. While 36 Fr is a good estimate of theaverage diameter of the various calibration tubes used, surgeons achievethe 2 cm IA offset by inserting their calibration tube, and stapling(i.e. estimating) slightly off the calibration tube, guessing at wherethey think 2 cm is.

To overcome this, the calibration tube may configured to flair out atits widest point (e.g., the maximum diameter 2 of the flared portion 3,13, and/or 23), which may be the same point where it may be lined upadjacent to the IA and the stapling guide, and may create a resultantdiameter of 2 cm. Inserting 2 cm as D₂ into F1, with L₁ still 1 cm, D₁may be calculated as 1.3634 cm, or 40.9014 Fr. Thus, at its widestpoint, the flared, calibration tube may be about 41 Fr. The rest of thetube may narrow as it moves proximally (e.g., to 4) until it reaches theconstant diameter or a smaller diameter such that this point in thetube, for example, the flared portion or maximum diameter thereof may beemphasized and easier to see from the surgeon's perspective. The 41 Frflair may subsequently narrow to something closer to the examplesdescribed herein, of around 15 or 16 Fr, so the rest of the tube may notbe as wide thereby facilitating fundus removal, which may be importantto the procedure. This narrowing from the maximum diameter (e.g., to 4and/or 5) may also allow the stapling guide to be positioned at the GEJ.Based on the width and shape of the stapling guide along with thediameter of the flared, calibration tube, a 1 cm offset from the GEJ anda squared off final cut may be provided (e.g., ensured). As such, in anexample, with a 10 mm stapling guide as a spacer, a calibration tubewith a 41 Fr flare portion and 16.9 Fr body, a surgeon may be able toachieve a safe distance from the incisura angularis and create a sleevegastrectomy tube with a consistent resultant diameter of 36 Fr.

Further, in one or more examples, other surgeons may want 1.5 cm or 2.5cm offset (e.g., even though a 2 cm offset at the IA may be believed tobe ideal) or some other distance along their staple line, so varioussizes of flared, calibration tubes may be used in one or more examplesherein to accommodate surgeon needs to maximize what they think is thebest, most effective sleeve. A table as shown in FIG. 33 with thedifferent sizes D₁, D₂, L₁, C₁, and/or C₂ may be provided to assist asurgeon in knowing the resultant sleeve volume with different sizes ofthe flared, calibration tube and/or the stapling guide. As such,according to examples herein, different flared, calibration tubes withdifferent diameters may be used with a stapling guide with a particularwidth to achieve a resultant sleeve diameter using the formulas F1 andF2 (e.g., calculated thereby).

FIG. 14A depicts a cross-section view of what the calibration tube andstapling guide combination will look like, with the adjacent resectionline along the guide. In an example herein, the formula F1 illustratedin FIG. 13A may be used to calculate the resultant sleeve circumference58 (02) from the circumference 54 of the calibration tube 50 used (C₁)and the width 60 (L₁) of a stapling guide 88 used as shown in FIG. 14A.

FIG. 14B depicts the resultant size of the sleeve once the calibrationtube and stapling guide may be removed. In one or more examples herein,the formula F2 as described herein may be used. Here, the diameter 56(D₂) of the resultant sleeve 40 g may be calculated from the diameter 52(D₁) of the calibration tube 50 used and the width 60 (L₁) of thestapling guide 88 used.

FIG. 15-18 depicts an example method or procedure that may be performedusing the flared, calibration tube 12 in one or more examples. As shownin FIG. 15, the calibration tube 12 may be positioned into an interiorof a stomach. For example (e.g., to position), the calibration tube 12may be inserted into a stomach 40 through the mouth and esophagus, andpassed down into the pylorus. A stapling guide 88 may be positioned onan exterior of the stomach relative to the calibration tube 12. Forexample, the stapling guide 88 may be passed around the stomach 40 asshown in FIG. 15 until it may be placed into position, with the proximalportion being on the GE junction 40 e as shown in in FIG. 17. Inexamples, the stapling guide 88 may be inserted through a trocar orlaparoscopic device to be positioned on the exterior of the stomach. Theflared, calibration tube 12 may then be pulled up by the surgeon untilthe flared portion 3 (e.g., the maximum diameter 2 thereof) of the tube14 may reach the incisura angularis 40 d as shown in FIG. 18. Becausethe gap between the incisura angularis 40 d and the stapling guide 88may be narrower than the flared portion 3 of the tube 14, as the flaredportion 3 moves vertically, it (e.g., via the point P′) may push (e.g.,a side of) the stapling guide 88 to the anatomic left that the staplingguide 88 may be positioned relative to. The surgeon may hold thestapling guide 88 in place at the GE junction 40 e, so that the staplingguide 88 may swing over and create a line (e.g., along point P1, P2, andP3 as shown in FIGS. 18 and 19 and opposite to a side positionedrelative to the calibration tube 12) up the stomach 40. In examples, P1may be the distance from the pylorus, which may vary from surgeon tosurgeon, but may typically be 2-6 cm from the pylorus on the gastricantrum along the greater curve (e.g., and may be 40 c of the resultantsleeve in FIG. 30), P2 may be adjacent to the incisura angularis, and P3may be the distance from the gastroesophageal junction (GEJ) (e.g., andmay be 40 e in FIGS. 15-18 and the resultant sleeve of FIG. 30).Further, P2 may be defined by an internal diameter of the flared portion3 of the tube 14 plus the spacer effect of the stapling guide (e.g.,using the formula F1 and F2 described with respect to FIGS. 13A-13B).The edge of the stapling guide 88 (e.g., where a surgical stapler may bedeployed and the staple line formed along P1, P2, and P3) may then beapproximately 2 cm off of the incisura angularis 40 d and approximately1.0 cm off of the GE junction 40 e (e.g., which as described herein maybe ideal for the surgeon).

In an example (e.g., when the stapling guide 88 may be so aligned), thestomach portions may be separated and reconnected along the edge of thestapling guide 88 at the path, staple line, resection line, or line(e.g., formed by P1, P2, and P3) using the surgical stapler such as aconventional surgical stapler. In the example described above, thestapling guide and the surgical stapler may be separate elements. In anadditional or alternative embodiment, however, the stapling guide andthe surgical stapler may be integrated into a single device. Once thatdevice may be aligned, such as with the calibration tube describedabove, it may be activated as described herein to form the staple linealong the vertical line thereby separating and reconnecting the stomachportions without further positioning.

The resultant sleeve 40 g, post stapling, may be illustrated in FIG. 30.The example dimensions (e.g., about 2 cm off of the incisura angularis40 d and about 1 cm off of the GE junction 40 e) may be provided for theresultant sleeve 40 g. For example, the resultant sleeve 40 g created orprovided by the path, resection line, staple line, or line may include adiameter of 1 to 3 cm near the first landmark (e.g., the IA 40 d), 2 to6 cm near a second landmark (e.g., a pylorus near 40c) of the stomach,and 0 to 2 cm near a third landmark (e.g., a gastroesophageal junction(GEJ) or GE junction 40 e) of the stomach.

FIGS. 19-23 illustrate another or additional example method or procedurethat may be performed using the flared, calibration tube 12 in one ormore examples. As shown, in examples, the method or procedure shown inFIGS. 19-23 may be used with the tubes 64, 74 with the flared portion 73described with respect to FIGS. 7-8 and/or the tube 34 with the flaredportion 33 described with respect to FIGS. 4-6 (not shown). FIG. 19shows the points P1, P2, and P3 on the stomach that a surgeon may wantto form a staple line as described herein (e.g., in FIGS. 15-18) tocreate a sleeve gastrectomy associate with such points. As describedherein, in one or more examples, different surgeons may have differentmethods and distances that they may be trying to achieve but they maywant it wider at P2 to prevent kinking around the bend although thewidth may vary from 50% wider to 300% wider between the surgeons.Further, with respect to P3 (e.g., 40 c in FIGS. 18 and 30), thesurgeons may try to stay 0.5 cm to 1 cm away from the GEJ to preservethe sling fibers of the cardia, which play a role in the antirefluxmechanism.

As shown in FIG. 20, an orogastric tube (e.g., as shown the first andsecond tubes 64, 74) with a flared portion (e.g., the flared portion 73)may be positioned in an interior of the stomach. For example (e.g., toposition), the first and second tubes 64, 74 may be inserted into thestomach 40 through the mouth and esophagus, and passed down into thepylorus. The tubes 64, 74 may be placed along the lesser curve such thatthe flared portion 73 with the wider diameter (e.g., the maximumdiameter 2) may be placed at the incisura angularis 40 d. The staplingguide 88 may be positioned on an exterior of the stomach relative to thetubes 64, 74. For example, the stapling guide 88 may be passed aroundthe stomach 40 as shown in FIG. 21 until it may be placed into position(e.g., near point P′), with the proximal portion being on the GEjunction 40 e as shown in in FIG. 22. For example, as shown in FIG. 21,the stapling guide 88 may be placed just medial to the desired resectionline, staple line, or line that may be defined by P1 to P2. In anexample, P2 may be defined by an internal diameter of the flared portion23 of the orogastric tube (e.g., 64 and 74) plus the spacer effect ofthe stapling guide (e.g., using the formula F1 and F2 described withrespect to FIGS. 13A-13B). As shown in FIGS. 21 and 22, the surgeon maymove the stapling guide 88 relative to the stomach 40 to align P2 withP3 such that P1, P2, and P3 may be in alignment and adjacent to alateral edge or side of the surgical clamp 88 (e.g., opposite to an edgeor side near or adjacent to the point P′) ready to be stapled therealongto form or create the staple line, line, resection line, or path. Asdescribed herein, the edge of the stapling guide 88 (e.g., where asurgical stapler may be deployed and the staple line formed) may beapproximately 2 cm off of the incisura angularis 40 d and approximately1.0 cm off of the GE junction 40 e (e.g., which as described herein maybe ideal for the surgeon) as shown in FIG. 22. The surgical stapler maybe actuated along the line defined by P1, P2, and P3 as describedherein.

The resultant sleeve 40 g, post stapling along the line of P1, P2, andP3, may be illustrated in FIG. 23. The resultant sleeve 40 g and itsdimensions (e.g., about 2 cm off of the incisura angularis 40 d andabout 1 cm off of the GE junction 40 e) may be provided. For example,the resultant sleeve 40 g created or provided by the path, resectionline, staple line, or line may include a diameter of 1 to 3 cm near thefirst landmark (e.g., the IA 40 d), 2 to 6 cm near a second landmark(e.g., a pylorus near 40c) of the stomach, and 0 to 2 cm near a thirdlandmark (e.g., a gastroesophageal junction (GEJ) or GE junction 40 e)of the stomach. In an example, the lengths of the lines defined by P1 toP2 and P2 to P3 may be changed during clamping thereby enabling theformation of the resultant sleeve 40 g and its dimensions. Theorientation and position of the stomach may be changed in examples bythe placement of the tubes 64, 74 and the stapling guide 88 and thestomach may snap back into shape after the manipulation and stapling.Thus, the interaction between the clamp 88 and the flared calibrationtube 64, 74 aligns the points P1, P2 and P3 to enable a straight stapleline to become a curved resultant sleeve.

FIGS. 24-28 illustrate another or additional example method or procedurethat may be performed using the flared, calibration tube 12 in one ormore examples. As shown, in examples, the method or procedure shown inFIGS. 24-28 may be used with the tubes 84 with the flared portion 83described with respect to FIG. 10 and/or the tubes 94, 104 with theflared portion 93,103 described with respect to FIGS. 11-12B (notshown). As shown in FIG. 24, similar to the method or proceduredescribed above with respect to FIGS. 15-18 and 1923, a surgeon may wantto form a staple line or resection line along the line defined by P1,P2, and P3.

In FIG. 25, a calibration tube such as the tube 84 with a balloon suchas the balloon 86 on the distal end (e.g., in state S1 as describedabove) that may form the flared portion 83 may be positioned in aninterior of the stomach. For example, the tube 84 may be inserted intothe stomach 40 through the mouth and esophagus, and passed down into thepylorus. The tube 84 may be inserted such that the balloon 86 that mayform the flared portion 83 may be placed along the lesser curve adjacentthe incisura angularis 40 d.

In an example, as shown in FIG. 26, a single cartridge stapler 110 orthe stapling guide 88 may be positioned on an exterior of the stomach.For example, the stapler 110 may be placed along P1 and P3 or thestapling guide 88 may be placed medial to P1 and P3. P1 and P3 may bestabilized by partial clamping the stapler 110 or positing the staplingguide 88 as described herein (e.g., above), and/or using similarstabilization with accessory instruments.

As shown in FIG. 27, the balloon 86 may be inflated (e.g., from state S1to state S2 as described above) to form the flared portion 83. Theflared portion 83 formed by the balloon 86 may align P2 with P1 and P3as described herein by moving or the stapler 110 and/or the staplingguide 88 and/or the stomach to create or demonstrate the stapling line,resection line, path, and/or the like. For example, the flared portion83 via the point P′ that may be near an edge or side of the stapler 110or stapling guide 88 may move the stapler 110 or stapling guide 88 tocreate the staple line, resection line, path, line, and/or the like(e.g., with the points P1, P2, and P3) along the edge of the stapler 110or stapling guide 110 opposite of the edge near the point P′. Asdescribed herein, the edge of the stapler 110 or the stapling guide 88(e.g., where a surgical stapler may be deployed and the staple lineformed) may be approximately 2 cm off of the incisura angularis 40 d andapproximately 1.0 cm off of the GE junction 40 e (e.g., which asdescribed herein may be ideal for the surgeon) as shown in FIG. 22. Thestapler may be actuated along the line defined by P1, P2, and P3 asdescribed herein above. This may also be illustrated for the tube 104 inFIG. 12B.

The resultant sleeve 40 g, post stapling along the vertical line of P1,P2, and P3, may be illustrated in FIG. 28. The resultant sleeve 40 g andits dimensions (about 2 cm off of the incisura angularis 40 d and about1 cm off of the GE junction 40 e) may be provided. For example, theresultant sleeve 40 g created or provided by the path, resection line,staple line, or line may include a diameter of 1 to 3 cm near the firstlandmark (e.g., the IA 40 d), 2 to 6 cm near a second landmark (e.g., apylorus near 40c) of the stomach, and 0 to 2 cm near a third landmark(e.g., a gastroesophageal junction (GEJ) or GE junction 40 e) of thestomach. After the stapler may be removed, the stomach may return to acurved shape after resection as described herein.

FIG. 29 may illustrate a representation of what an example method orprocedure may include if one of several alternative or additionalexamples may be used. Here, the example device 66 may be used similar tothe flared calibration tube 12 in that it may help align the staplingguide 88 and create proper spacing as described herein to provide aresultant sleeve 40 g.

Additional or alternative examples of the calibration tubes that may beused in FIG. 29 may be provided in FIGS. 31 and 32. FIG. 31 illustratesa calibration tube 62 with lights 64 running down the length of the tube62. The lights 64 may assist the surgeon in seeing the placement andoutline of the tube and improve their understanding of what theirresultant sleeve will look like. The exact number and spacing of thelights 64 may vary to achieve the desired illumination. Further, FIG. 32illustrates a specialized balloon bougie 68 that may be inflated tocreate a variable-sized balloon 70 that may be used to regulate thespacing to the stapling guide or single cartridge sleeve gastrectomystapler and the volume of the sleeve. According to examples herein, theballoon 70 may be configured to have a consistent size and shape suchthat the sleeve may be sized and shaped to this template with the use ofthe stapling guide or single cartridge sleeve gastrectomy stapler. Thus,the balloon 70 may act as a mold from which to create the resultantsleeve lumen at a constant pressure (15 to 100 cm of water). Usingeither the tube 62 or the bougie 68, a resultant sleeve may be providedwith the dimensions described herein as shown by 40 g in FIG. 30 orsimilar dimensions to that of 40 g.

While several devices and components thereof have been discussed indetail above, it should be understood that the components, features,configurations, and methods of using the devices discussed are notlimited to the contexts provided above. In particular, components,features, configurations, and methods of use described in the context ofone of the devices may be incorporated into any of the other devices.Furthermore, not limited to the further description provided below,additional and alternative suitable components, features,configurations, and methods of using the devices, as well as variousways in which the teachings herein may be combined and interchanged,will be apparent to those of ordinary skill in the art in view of theteachings herein.

Versions of the devices described above may be actuated mechanically orelectromechanically (e.g., using one or more electrical motors,solenoids, etc.). However, other actuation modes may be suitable as wellincluding but not limited to pneumatic and/or hydraulic actuation, etc.Various suitable ways in which such alternative forms of actuation maybe provided in a device as described above will be apparent to those ofordinary skill in the art in view of the teachings herein.

Versions of the devices described above may have various types ofconstruction. By way of example only, any of the devices describedherein, or components thereof, may be constructed from a variety ofmetal and/or plastic materials.

Having shown and described various versions in the present disclosure,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, versions, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

What is claimed is:
 1. A method for performing a sleeve gastrectomy, themethod comprising the steps of: providing a first medical deviceincluding: (i) a tube for insertion into an interior of a stomach, thetube having a proximal end and a distal end; and (ii) a balloon portion,the balloon portion having a first deflated configuration for insertioninto the interior of the stomach and a second inflated configuration,wherein the balloon portion is positioned at about the distal end of thetube; providing a second medical device, the second medical device beinga single-use linear stapler, wherein the single-use linear stapler has asingle cartridge such that a complete gastrectomy staple line is formedwith the single cartridge along a resection line, the resection linebeing defined at least partially by the balloon portion in the secondinflated configuration in cooperation with the single-use linearstapler; inserting the first medical device into an interior of astomach; positioning the second medical device on an exterior of thestomach relative to and anatomically lateral to the first medicaldevice; and cutting the stomach using the second medical device toresect a portion of the stomach to form a sleeve.
 2. The method of claim1, further comprising operating the second medical device to provide astaple line.
 3. The method of claim 1, wherein the second medical devicehas a first end and a second end and having a length therebetween, thelength extending from about a pylorus of the stomach to about agastroesophageal junction (GEJ) of the stomach.
 4. The method of claim3, wherein the second medical device is positioned relative to andanatomically lateral to the balloon portion of the first medical devicesuch that the first end of the second medical device is positioned aboutone centimeter to about three centimeters laterally from the balloonportion of the first medical device.
 5. The method of claim 3, whereinthe second medical device is positioned about zero to about twocentimeters relative to and anatomically lateral to the calibration tubeat the GEJ.
 6. The method of claim 3, wherein the second end of thesecond medical device is positioned anatomically lateral to thecalibration tube at the GEJ.
 7. The method of claim 6, wherein thesecond end of the second medical device is positioned about zero toabout two centimeters relative to the calibration tube at the GEJ. 8.The method of claim 3, wherein the second medical device is positionedrelative to and anatomically lateral to the first medical device suchthat a substantially linear resection line for the sleeve gastrectomy isdefined by the balloon portion of the first medical device and thesecond medical device;
 9. The method of claim 1, wherein the balloonportion includes a non-compliant balloon.
 10. The method of claim 1,wherein the tube has a first diameter and the balloon portion has asecond diameter larger than the first diameter.
 11. The method of claim1, wherein, after being inserted, the balloon portion is positioned atabout an incisura angularis along a lesser curvature of the stomach. 12.The method of claim 1, wherein the balloon portion has a first deflatedposition for insertion into the stomach and a second inflated positionfor laterally displacing the lesser curvature of the stomach.
 13. Themethod of claim 12, wherein the balloon portion has a first diameter inthe first deflated position and a second diameter in the second inflatedposition, wherein the second diameter is from about 0.5 cm to about 2cm.
 14. The method of claim 13, wherein the first diameter of theballoon portion in the first deflated position is substantially the sameas the first diameter of the tube.
 15. The method of claim 1, wherein aninteraction between the first medical device and the second medicaldevice positions the second medical device in a desired position. 16.The method of claim 1, wherein positioning the second medical devicefurther comprises: moving the first medical device from a first positionto a second position, wherein the movement of the first medical devicefrom the first position to a second position causes a correspondingmovement of the second medical device from a first position to a secondposition.
 17. A method for performing a sleeve gastrectomy, the methodcomprising the steps of: providing a first medical device including: (i)a tube portion for insertion into an interior of a stomach; and (ii) aballoon portion, the balloon portion having a first deflatedconfiguration for insertion into the interior of the stomach and asecond inflated configuration; providing a second medical device, thesecond medical device being a linear stapler, wherein the linear staplerhas a single cartridge such that a complete gastrectomy staple line isformed with the single cartridge along a resection line, the resectionline being defined at least partially by the balloon portion in thesecond inflated configuration in cooperation with the linear stapler;inserting the first medical device into an interior of a stomach;positioning the second medical device on an exterior of the stomachrelative to and anatomically lateral to the first medical device; andcutting the stomach using the second medical device to resect a portionof the stomach to form a sleeve.
 18. The method of claim 1, furthercomprising operating the second medical device to provide a staple line.19. The method of claim 1, wherein an interaction between the firstmedical device and the second medical device positions the secondmedical device in a desired position.
 20. The method of claim 1, whereinpositioning the second medical device further comprises: moving thefirst medical device from a first position to a second position, whereinthe movement of the first medical device from the first position to asecond position causes a corresponding movement of the second medicaldevice from a first position to a second position.